Ron Lanton 5/23/22 Ron Lanton 5/23/22

U.S. Hemp Roundtable Highlights New Industry CBD Study

The U.S. Hemp Roundtable is highlighting a study conducted by Validcare “confirms prior research that orally-ingested cannabidiol (CBD) has a strong safety profile, providing data that addresses FDA’s specific safety concerns regarding CBD, with the results indicating that daily consumption across a range of typical retail products and serving sizes is not associated with elevated liver tests, low testosterone levels, or daytime drowsiness.”

“We are excited to report that the ‘real-world data’ that FDA has been soliciting addresses the agency’s safety concerns,” stated Jonathan Miller, General Counsel to the U.S. Hemp Roundtable, the hemp industry’s national advocacy organization. “The time has come for FDA to regulate CBD and other hemp derivatives. If FDA does not act, we call on Congress to pass legislation such as HR 841, HR 6134 and S. 1698 which would require the FDA to develop regulatory pathways for the sale of hemp extracts like CBD in ingestible form.”

The FDA is the deciding factor in determining whether CBD products make it in the marketplace. This study could help push innovation in the right direction and answer the lingering safety questions and concerns that we have seen in previous FDA product rulings.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues. Contact us to learn about how either our legal or lobbying services can help you attain your priorities.

Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.

Ron Lanton 12/6/21 Ron Lanton 12/6/21

New Congressional CBD Bill Introduced to Give Policy Clarity for CBD Products

Congress has introduced the CBD Product Safety and Standardization Act “that will establish federal standards for CBD food and beverage products to protect consumers and provide marketplace stability for farmers, producers, and retailers.”

Congress has introduced the bi-partisan CBD Product Safety and Standardization Act “that will establish federal standards for CBD food and beverage products to protect consumers and provide marketplace stability for farmers, producers, and retailers.” The bill is sponsored by U.S. Representatives Rice (NY-04), Griffith (VA-09), Craig (MN-02), and Crenshaw (TX-02).

According to the bill’s press release:

“While the 2018 Farm Bill removed hemp-derived cannabidiol (CBD) from the Controlled Substances Act, it did not make changes to existing Food and Drug Administration (FDA) law or regulatory policies governing its use in FDA-regulated products. Since then, the market for CBD products has exploded, and CBD is ubiquitously available to consumers in oils, cosmetics, supplements, and foods, and it is even marketed in products for pets. The discrepancy between the Controlled Substances Act and FDA law has created a regulatory gray area in which CBD is widely available but unregulated – and considered illegal – by FDA.

The bipartisan CBD Product Safety and Standardization Act would allow FDA to regulate CBD as it would any other food ingredient and subject these products to enforceable safeguards to ensure accountability. It also charges the agency with establishing CBD content limits and packaging and labeling requirements and determining in which categories of food CBD is appropriate for use. This bill will help distinguish responsible players from bad actors that ignore federal requirements for quality, manufacturing, labeling, and claims, and it will bring safety and clarity to the market.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Ron Lanton 8/20/21 Ron Lanton 8/20/21

Latest FDA Refusal to Approve CBD as a Food Ingredient or Supplement Causes Stakeholder Frustration

The federal Food & Drug Administration (“FDA”) has refused to consider an application by Charlotte’s Web Holdings, Inc. (“Charlotte’s Web”) for a CBD product to be sold as a dietary ingredient. This decision was outlined in an FDA letter to the company found here.

“Under 21 U.S.C. § 350b(a), the manufacturer or distributor of a dietary supplement containing a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such new dietary ingredient will reasonably be expected to be safe. FDA reviews this information to determine whether it provides an adequate basis for such a conclusion. Under 21 U.S.C. § 350b(a)(2), there must be a history of use or other evidence of safety establishing that the new dietary ingredient, when used under the condition recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe. If this requirement is not met, the dietary supplement is considered to be adulterated under 21 U.S.C. § 342(f)(1)(B) because there is inadequate information to provide reasonable assurance that the new dietary ingredient does not present a significant or unreasonable risk of illness or injury.

FDA has carefully considered the information in your notification and other available information and determined that your NDI 1202 cannot be used in dietary supplements pursuant to the dietary supplement exclusion provision in 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act). The definition of a dietary supplement is set forth in 21 U.S.C. § 321(ff) (section 201(ff) of the Act), which states in relevant part:

(ff) The term ‘dietary supplement’ . . . (3) does . . . (B) not include – (i) an article that is approved as a new drug under section 355 of this title . . . or (ii) an article authorized for investigation as a new drug . . . for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,

which was not before such approval . . . or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.

FDA has concluded that CBD products are excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act).

We also conclude that, even if your NDI 1202 was not excluded from the definition of dietary supplement, the agency has concerns about the adequacy of safety evidence included in your submission as a basis for concluding that a dietary supplement containing NDI 1202 will reasonably be expected to be safe under the conditions of use described in your notification.”

Many in the industry were hoping to get some additional clarity on how FDA would oversee CBD and whether FDA’s views have evolved. Unfortunately that is not the case yet. CBD continues to be an item that has an uneven regulatory scheme.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

If you are either thinking about or are currently selling CBD and are unsure how your business model fares, contact Lanton Law so that we can go over your business model, assess potential risks and help you plan for both pending legislative and regulatory actions.

Ron Lanton 3/26/21 Ron Lanton 3/26/21

SAFE Banking Act introduced Into the U.S. Senate

U.S. Senators Merkley (D-OR) and Daines (R-MT) have introduced the Secure and Fair Enforcement (SAFE) Banking Act, to ensure that legal cannabis operators have access to banking services. The bill can be viewed here.

According to the press release, the proposed bill prevents federal banking regulators from the following:

Prohibiting, penalizing or discouraging a bank from providing financial services to a legitimate state-sanctioned and regulated cannabis business, or an associated business (such as an lawyer or landlord providing services to a legal cannabis business);
Terminating or limiting a bank’s federal deposit insurance solely because the bank is providing services to a state-sanctioned cannabis business or associated business;
Recommending or incentivizing a bank to halt or downgrade providing any kind of banking services to these businesses; or
Taking any action on a loan to an owner or operator of a cannabis-related business.

Furthermore, the press release states that bill also:

Creates a safe harbor from criminal prosecution and liability and asset forfeiture for banks and their officers and employees who provide financial services to legitimate, state-sanctioned cannabis businesses, while maintaining banks’ right to choose not to offer those services. The bill also provides protections for hemp and hemp-derived CBD related businesses.
Requires banks to comply with current Financial Crimes Enforcement Network (FinCEN) guidance, while at the same time allowing FinCEN guidance to be streamlined over time as states and the federal government adapt to legalized medicinal and recreational cannabis policies.

The House version has already been filed for this Congressional session. Additional background on this bill and issue can be found on Congressman Perlmutter’s website.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically our cannabis practice helps all supply chain entities from growers, financiers, suppliers, dispensers to ancillary services.

Ron Lanton 3/9/21 Ron Lanton 3/9/21

New Psychedelic ETF About To Hit the Market

There is a new March 5, 2021 U.S. Securities Exchange Commission (SEC) filing that will allow investors to gain exposure to the psychedelic and cannabis industries.

There is a new March 5, 2021 U.S. Securities Exchange Commission (SEC) filing that will allow investors to gain exposure to the psychedelic and cannabis industries. According to the fling, the Defiance Next Gen Altered Experience ETF is:

The Index is a rules-based index that tracks the performance of a portfolio of life sciences companies conducting federally legal medical activities in the psychedelics, medical cannabis, hemp, and cannabidiol (“CBD”) industries whose common stock or depositary receipts are listed on a U.S. or Canadian exchange. Psychedelic drugs, also known as hallucinogens, are a group of substances, including psilocybin, that are used to change and enhance sensory perceptions, thought processes, and energy levels. Medical cannabis, also known as medical marijuana, refers to the use of parts of the marijuana plant, such as hemp and the plant’s chemicals, for the treatment of a variety of diseases or medical conditions. Hemp is a type of cannabis plant whose stalks and seeds are used for a variety of commercial products.

While Lanton Law is not making any statements about whether people should invest in this or not, we are simply monitoring the industry to let interested stakeholders know about the developments within the cannabis market.

Ron Lanton 3/2/21 Ron Lanton 3/2/21

Virginia Votes to Legalize the Sales & Recreational Use of Marijuana

Virginia has taken one step closer to becoming the first southern state to legalize marijuana. If enacted Virginia would follow Washington D.C. along with fifteen other states to do so. The proposed legislation would allow the possession of up to one ounce of marijuanato become legal starting January 1, 2024. This would be at the same time as sales and a regulatory scheme overseeing the new marijuana marketplace would take off. The bill is awaiting Governor Northam’s signature who is expected to sign the measure into law.

Ron Lanton 10/9/20 Ron Lanton 10/9/20

Lanton Law Opens Cannabis Practice

Lanton Law believes that the cannabis market will continue to evolve and expand. Notwithstanding this market potential is the fact that medical and adult-use cannabis operations are confronted with a complex patchwork of state and federal laws and regulations that we assist a variety of businesses with.

Whether you are a public or private cultivator, processor, distributor, dispensary, or an ancillary service related to the medical and/or adult-use cannabis business, we can help.

Lanton Law assists our cannabis clients with the following services:

Offer strategic advice on the federal and state outlook
Contract and lease drafting
Corporate formation & governance
Shareholder agreements
Administrative representation
Trademarks and copyrights
FDA, USDA and FTC regulatory compliance
Banking and finance
Licensing
State and local permits
Lobbying
Investor & early stage company issues
Mergers and acquisitions
Non-Compete and Non-Disclosure agreements
Labor and employment
General counsel services

Ron Lanton 9/27/20 Ron Lanton 9/27/20

FDA Cannabis Draft Guidance Comment Period Closes

On September 21st the FDA closed its comment period related to cannabis. Back in July the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.”

This draft guidance outlined FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and cannabis-derived compounds for clinical research; general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, extracts, and finished products. This draft guidance had been developed to help support clinical research into development of cannabis and cannabis-derived products.

Additional information on the draft guidance can be found here.

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

Ron Lanton 12/26/19 Ron Lanton 12/26/19

Conflicting CBD Activity Calls for Increased Compliance and Business Planning

Lanton Law gave a December 2019 webinar with the American College of Apothecaries ACA on CBD. Since then we have seen two significant developments.

The first was with the U.S. Food and Drug Administration (FDA) itself. In November 2019, the industry saw the agency’s announcement of 15 warning letters it sent to companies for illegally selling products containing CBD in “ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA shortly afterwards issued a revised Consumer Update detailing safety concerns about CBD products more broadly. In the document titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” FDA indicated that “Based on the lack of scientific information..., it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”

With the industry already facing several compliance questions, this new information from FDA has definitely made this issue even more confusing.

States on the other hand have been pressing forward with making their own policies. In New York, Governor Cuomo signed (S.6184/A.7680) which establishes a regulatory framework for the production and sale of hemp and hemp extract in New York State.

According to the Governor’s press release “The measure also requires the hemp industry to test and label their products, protecting consumers from potential harm. The legislation was signed pursuant to a chapter agreement, which provided for a more streamlined regulatory pathway for hemp products, granted the Department of Agriculture and Markets supervision over hemp growers and the Department of Health supervision over hemp extract; created a registration requirement for sellers of hemp extract products; made conforming regulatory changes to the 2018 Farm Bill; and defers decision making on hemp extracts, including CBD, as additives for food and beverages.”

The state will host a hemp summit in January to continue policy discussions on this issue.

With the collective market for CBD sales expected to exceed $20 billion in the United States by 2024, according to BDS Analytics and Arcview Market Research, there are many stakeholders who would benefit from clarity in this area. If you are either thinking about or are currently selling CBD and are unsure how your business model fares, contact Lanton Law so that we can go over your business model, assess potential risks and help you plan for both pending legislative and regulatory actions.

Ron Lanton 11/25/19 Ron Lanton 11/25/19

New Lanton Law Webinar on December 4th with the American College of Apothecaries (ACA)

We have a new webinar on December 4, 2019 via the American College of Apothecaries (ACA) on CBD.

Cannabidiol (CBD) products are flooding the market at an alarming rate. Many consumer stakeholders are excited about this new product line, while providers such as pharmacies, natural health food stores, and other retailers are casting a watchful eye; torn between developing market strategies to meet demand while also watching for state and federal regulatory oversight. This webinar will discuss the various aspects of CBD regulations and market trends to give stakeholders a better understanding of the CBD environment for patient and market opportunities.

Ron Lanton 10/18/19 Ron Lanton 10/18/19

Cannabidiol Made Simple

Cannabidiol (CBD) has certainly drawn significant attention over the past few months. Marked by the recent passage of the Farm Bill and the FDA’s hearing on CBD at the end of May, the curiosity about and demand for the products have never been stronger. Unfortunately, misinformation on the effects of CBD remains rampant, including details on whether combining CBD with food affects the body’s absorption and conflicting reports on the various differences in state regulation.

This article appeared in Specialty Pharmacy Times.

This article examines the basis of CBD use in health care along with the recent major regulatory discussions surrounding this emerging trend.

Market Trends
Market projections for CBD have varied widely. A study by cannabis investigators BDS Analytics and Arcview Market Research projected the collective market for CBD sales to exceed $20 billion in the United States by 2024. The study also showed that US retail sales of CBD consumer products in 2018 were between an estimated $600 million and $2 billion. The investigators estimated that CBD products could generate approximately $16 billion in retail sales by 2025.1

What Is CBD?
According to the FDA, “Cannabis is a plant of the Cannabaceae family and contains more than 80 biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class ‘Marihuana’ (commonly referred to as ‘marijuana’) [21 U.S.C. 802(16)].”

The FDA classifies marijuana as a schedule I drug under the CSA because of a high potential for abuse, largely attributable to the psychoactive effects of THC and a lack of agreement on acceptable medical use in the United States.2

CBD Regulation
The passage of the 2018 Farm Bill, also known as the Agriculture Improvement Act of 2018, reauthorized many expenditures from the Agricultural Act of 2014. Enacted on December 20, 2018, the law deemed hemp a legal substance and set the THC threshold of CBD products to 0.3% on a dry weight basis.2

Most important, the law maintains the FDA’s authority to regulate cannabis and its derivatives, as any product claiming therapeutic benefits derived from CBD requires FDA approval for its intended use before going to market. The Farm Bill stated that significant shared state–federal regulatory power over hemp cultivation and production will be instated. State departments of agriculture must consult with their governors and chief law enforcement officers to devise a regulatory plan to submit to the secretary of the US Department of Agriculture (USDA) for approval. Hemp cultivators in states that opt not to devise a program will need to apply for licenses and comply with a federally run program constructed by the USDA.

Before the passage of the Farm Bill, CBD took a major step forward with the FDA approval of Epidiolex. On June 25, 2018, the oral solution was approved for the treatment of seizures associated with 2 rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years and older. This was the first FDA-approved drug containing a purified substance derived from marijuana. It was also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.3

What is happening in state legislatures? Thirty-four states, the District of Columbia, Guam, Puerto Rico, and the US Virgin Islands have approved comprehensive medical marijuana programs, and 12 states allow the use of products containing low THC and high CBD for medical reasons in limited situations or as a legal defense, according to the National Conference of State Legislatures. Furthermore, as of June 5, 2019, 13 states and territories have approved the adult use of cannabis.4

On May 31, 2019, the FDA held a public hearing to gather information from industry stakeholders on the use of CBD in cosmetics, dietary supplements, and food. The FDA made no new regulatory announcements, as the agency recognized that further discussion is needed before it can determine the appropriate regulatory pathway for these products. This point was emphasized by former FDA Commissioner Scott Gottlieb, MD, who outlined the need for a high-level internal agency to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed. He also emphasized the need to find answers to frequently asked questions to help the public understand how the FDA’s requirements apply to these products, as well as next steps for the FDA.

What Is Next for CBD?
Pharmacy professionals should monitor statements from the FDA in the immediate future to see how it intends to regulate CBD. Further, they can glean regulatory insight by examining warning letters, such as the 3 recent warnings the agency sent to companies making unsubstantiated claims regarding the ability of their products to limit, treat, or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious conditions without sufficient evidence and legally required FDA approval.

The USDA’s Agricultural Marketing Service (AMS) is another place to look for clues to CBD oversight. Earlier this year, the AMS issued a notice to trade over hemp production and cultivation. Cannabis-based stocks such as GW Pharmaceuticals, OrganiGram, Tilray, and the Canopy Growth Corporation could offer further insights into how the FDA will regulate this industry.

However, my closing advice for retailers looking to enter this market is to learn how your hemp products are created, processed, and tested for contaminants, because no uniform standard exists. Lastly, I would advocate for the use of counsel to ensure that the products you wish to sell comply with current FDA regulations and to help you understand the different state regulatory requirements surrounding CBD.

References

U.S. CBD market anticipated to reach $20 billion in sales by 2024 [news release]. Boulder, CO: BDS Analytics; May 9, 2019. bdsanalytics.com/u-s-cbd-market-anticipated-to-reach-20-billion-in-sales-by-2024. Accessed June 8, 2019.
FDA regulation of cannabis and cannabis-derived products: questions and answers. FDA website. fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers. Updated April 2, 2019. Accessed June 8, 2019.
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy [news release]. Silver Springs, MD: FDA. www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms. Accessed June 8, 2019.
State medical marijuana laws. National Conference of State Legislatures website. ncsl.org/research/health/state-medical-marijuana-laws.aspx. Published June 5, 2019. Accessed June 8, 2019.